The field of the present invention is valve mechanisms for use in the human body.
Valves play an important role in a number of bodily functions. One such physiologic valve is in the urinary tract. Valve failure in this system leads to urinary incontinence, a significant health issue. Urinary incontinence is estimated to affect some ten million Americans. The full extent of this problem is unknown because less than half of affected adults are believed to actually seek medical attention.
Devices are available to assist in the control of urinary incontinence. Such devices include external valves, valves extending throughout the lower urinary tract and into the bladder, devices extending through long portions of the urethra and implanted protheses as well as injected bulking agents which support the urethral sphincter to enhance operation. Such devices are often inconvenient, uncomfortable and/or require surgical insertion. Other devices are considered overly intrusive.
Native valves are also found in cardiovascular systems. In veins, native venous valves promote one-way flow toward the heart from the periphery. Diseases exist such as venous thrombosis and thrombophlebitis which can render native venous valves incompetent, resulting in edema. Replacement of these native valves with artificial ones could provide substantial health benefits.
The pulmonic valve associated with the heart is yet another native flow control mechanism which can exhibit incompetence either congenitally, through disease or iatrogenically due to treatment of pulmonary stenosis. A one-way valve positioned distal to the native pulmonic valve within the pulmonary artery could be of substantial benefit in overcoming this problem.
The present invention is directed to a body fluid flow control device which includes an ability to seal about the device in the fluid passageway, a placement and retention format for the device and a valve body capable of either or both a pressure threshold for operation and a one-way flow restriction. The valve body preferably end bulk resilience and a passage therethrough which is closed by that bulk resilience. This may be defined by an elastomeric or other polymeric body with a passage therethrough cut without the removal of material. A single slit, a cross or a star shaped cut are included among the possibilities. One-way flow may be accomplished through a flap or other inhibitor physically impeding flow in one direction or by a configuration of the valve to employ passage pressure to prevent opening.
In a separate aspect of the present invention, such devices as contemplated above are combined with mechanisms to assist in transforming the state of the device from insertion to anchoring.
Accordingly, it is a principal object of the present invention to provide a flow control device for the human body such as for urinary, venous or pulmonic placement. Other and further objects and advantages may appear hereinafter.